Kornimate/medical-research-clean huggingface dataset:
a study of cs1001 in subjects with relapsed or refractory classical hodgkin lymphoma

Conditions: Hodgkin Lymphoma

Summary: this is a multicenter, single-arm phase ii study to evaluate the efficacy and safety of cs1001 monotherapy for relapsed/refractory classical hodgkin lymphoma (rr-chl)

eligible subjects with rr-chl who failed at least two prior lines of therapies are planned to receive cs1001 1200 mg intravenous infusion every three weeks until progression of disease, intolerable toxicity, consent withdrawn or death.the primary endpoint of this trial is objective response rate (orr), as assessed by independent radiological review committee (irrc) based on criteria for response assessment of lymphoma: lugano 2014 classification.

Eligibility criteria:
inclusion criteria: 1. subjects with histologically confirmed chl at study site. 2. relapsed or refractory chl that failed at least two lines of systemic therapy. 3. ecog ps of 0-2. 4. subjects with at least one measurable lesion at baseline. 5. subjects treated by prior anti-cancer therapy whose toxicity resolved to baseline or =\< grade 1 according to common terminology criteria for adverse events (ctcae) v4.03 6. subjects who agree to use highly effective contraception. exclusion criteria: 1. nodular lymphocyte predominant hodgkin lymphoma or grey zone lymphoma. 2. primary site in central nervous system (cns) or cns involvement. 3. subjects currently participating in other clinical studies or use of any investigational drug within 4 weeks prior to the first dose of cs1001. 4. subjects who had systemic corticosteroid or any other immunosuppressive therapy within 14 days prior to the first dose of cs1001. 5. subject who had chemotherapy, immune therapy or biological therapy as systemic anti-cancer treatment within 28 days prior to the first dose of cs1001. 6. receipt of traditional medicinal herbal preparations within 7 days prior to the first dose of cs1001. 7. known history of human immunodefiency virus (hiv) infection and/or acquired immune deficiency syndrome. 8. subjects with active hepatitis b or c infection. 9. subjects with active tuberculosis infection. 10. subjects who received prior therapy with anti-pd-1, anti-pd-l1 or anti ctla-4 monoclonal antibody. 11. female subjects who are pregnant or breast-feeding. for more information regarding trial participation, please contact at cstonera@cstonepharma.com
adapting a stress management intervention to reduce cardiovascular disease risk

Conditions: Stress; Blood Pressure; Cardiovascular Diseases (CVD)

Summary: women living with hiv have 2-4x higher risk for cardiovascular disease compared to women without hiv, with women living with hiv in the southern us being particularly at risk. while an increased prevalence of traditional risk factors (e.g., hypertension, diabetes, and obesity) partially explain this risk, evidence suggests that increased exposure to structural and social stressors (e.g., poverty, discrimination, and stigma) among women living with hiv in the south negatively contribute to cardiovascular disease disparities through their impact on stress. the stress management and resiliency training (smart) program is an effective, evidence-based intervention proven to improve resiliency to environmental stressors and reduce the physiologic responses to stress which contribute to cardiovascular disease. while the smart program has demonstrated efficacy in a wide range of populations and settings, it has not been designed for or tested among women living with hiv in the south, where unique cultural and faith-based context may diminish the uptake and value of the intervention to mitigate cardiovascular disease risk. the purpose of this study is to adapt the evidence-based smart program in consideration of the needs and contexts of women living with hiv in the southern us and pilot the adapted intervention to establish the feasibility, acceptability, and preliminary impact of the adapted intervention to reduce stress and mitigate cardiovascular disease risk among this population.


Eligibility criteria:
inclusion criteria: 1. cis-gender females at least 18 years of age 2. hiv-seropositive and a patient of the recruiting clinic 3. english speaking exclusion criteria: 1. severe mental illness 2. not being willing able to provide informed consent 3. not willing or able to attend study visits

Keywords: stress resiliency meditation blood pressure cardiovascular risk
prospective randomized study comparing one or two high dose chemotherapy regimen followed by autologous stem cell transplantation

Conditions: Acute Myeloid Leukemia

Summary: first randomization: after inclusion use of daunorubicin (arm d) or idarubicin (arm i) as anthracyclin during all courses of chemotherapy (induction, consolidation courses before asct) second randomization: after achieving 1st cr: all patients received non intensive consolidation course familial hla typing required for all patients patients with hla-identical sibling: patients with very good prognostic factors (cbf leukemias, wbc \< 30 giga/l at diagnosis, 1st cr after one induction course) = arm c: no allogeneic stem cell transplantation in 1st cr; received 2 more courses of intensive consolidation chemotherapy all others patients received an allogeneic transplant for patients aged less than 51 = arm m: upfront myeloablative conditioning regimen for patients aged over 51 and less than 61= arm m: intensive chemotherapy consolidation course.


Eligibility criteria:
inclusion criteria: * patients aged 15 to 60 years * diagnosis untreated aml (fab 0 to 2, 4 to 7): more than 20% marrow blasts according to who classification * signed informed consent required exclusion criteria: * aml3 subtype * previous diagnosis of myelodysplastic syndrome (mds) or myeloproliferative disease; patients with previous chemotherapy or radiotherapy were eligible if they had no previous diagnosis of mds * isolated extramedullary disease * inadequate performance status (≥ 3), cardiac function (lvef \ 150 µmol/l), liver functional tests (bilirubin \> 35 µmol/l, liver enzymes \> 4 times normal values); life expectancy \< 3 months * informed consent refusal

Keywords: acute myeloid leukemia in first complete remission
effects of inspiratory flow waveforms on preload

Conditions: Cardiac Output, Low

Summary: the clinical usefulness of inspiratory flow pattern manipulation during mechanical ventilation remains unclear. the aim of this study was to investigate the effects of different inspiratory flow waveforms, i.e. constant and decelerating, on cardiac preload in mechanically ventilated patients assessed by arterial pulse pressure variation (ppv) and inferior vena cava distensibility.

during mechanical ventilation the lungs can be inflated with different pressure and flow waveforms. originally the piston-driven mechanical ventilators generated a quasi-sinusoidal flow waveform, whereas the newer electronically controlled ventilators can also produce constant and decelerating waveforms. according to several theoretical,animal and clinical studies,the inspiratory flow waveform affects the distribution of the inspired gas as well as respiratory mechanics and gas exchange. however, other studies failed to show any significant effect.but there is no study interested to the effects of inspiratory flow waveforms on cardiac preload. thus, the clinical usefulness of inspiratory flow pattern manipulation remains unclear, though the capacity for selection of different inspiratory flow waveforms is provided by most modern, microprocessor-equipped ventilators. therefore, the purpose of this study was to compare the effects of flow patterns (sinusoidal, constant and decelerating) on dynamic measurements of cardiac preload dependence such as arterial pulse pressure variation (δpp) and distensibility index of the inferior vena cava (divc).

Eligibility criteria:
inclusion criteria: * mechanical ventilation * volume assistcontrol ventilation * sinus rhythm exclusion criteria: * pressure mode * arrhythmia

Keywords: inspiratory flow pattern mechanical ventilation cardiac preload arterial pulse pressure variation inferior vena cava collapsibility
valvosoft first-in-human study in severe symptomatic aortic stenosis

Conditions: Aortic Valve Stenosis

Summary: this is a prospective, controlled, single-arm clinical investigation for the treatment of subjects with severe symptomatic aortic valve stenosis using valvosoft® pulsed cavitational ultrasound therapy (pcut) - first-in-human

cardiawave has developed a new non-invasive, real-time image-guided, therapeutic approach to treat patients suffering from calcified aortic stenosis. cardiawave's valvosoft device is a new ultrasound therapy based on a disruptive technology involving delivering an extremely precise and focused ultrasound beam to perform a reparative effect on the aortic valve leaflets, softening the valve's tissues, restoring leaflet mobility, and therefore improving the overall clinical status related to the aortic valve stenosis. in this study, a brai-mri is performed before the procedure and 24-72 hours after the procedure to detect cerebrovascular events.this is a fim study

Eligibility criteria:
inclusion criteria: * subjects suffering from severe symptomatic aortic valve stenosis according to esc 2017 definition, including subjects with a bicuspid valve. * patient is not eligible for tavr/savr according to local heart team. * age ≥18 years. * subjects who are willing to provide a written informed consent prior to participating in the study. * subjects who can comply with the study follow up or other study requirements. * patient is eligible for the valvosoft procedure according to crc. exclusion criteria: * subjects with any electrical device implanted. * subjects with unstable arrhythmia not controlled by medical treatment. * subjects with implanted mechanical valve in any position or bio prosthetic valve in aortic position. * subjects with complex congenital heart disease. * chest deformity. * cardiogenic shock. * history of heart transplant. * subjects requiring other cardiac surgery procedures (bypass graft surgery, mitral valve procedure, tricuspid valve procedure) within one month after treatment. * thrombus in heart. * acute myocardial infarction (mi), stroke or transient ischemic attack (tia) within one month prior to enrolment\*. * subjects who are pregnant or nursing. * subjects who are participating in another research study for which the primary endpoint has not been reached.

Keywords: symptomatic aortic valve stenosis ultrasound non-invasive
safety and biologic activity study of gevokizumab to treat erosive osteoarthritis of the hand

Conditions: Osteoarthritis

Summary: the purpose of this proof-of-concept study is to determine whether gevokizumab is effective in the treatment of active inflammatory, erosive osteoarthritis of the hand.


Eligibility criteria:
inclusion criteria: * diagnosis of hand osteoarthritis * joint tenderness and/or redness * at least one erosion by x-ray (as determined by the central reader) * contraceptive measures adequate to prevent pregnancy during the study exclusion criteria: * history of inflammatory disease other than hand eoa including: secondary post-traumatic oa; rheumatoid arthritis; spondylarthropathies; erosion of the ulnar styloid process; psoriatic arthritis; skin psoriasis; erosions of the wrist; fibromyalgia * history of gout, pseudogout, or hemochromatosis * history of allergic or anaphylactic reactions to monoclonal antibodies * history of recurrent or chronic systemic infections * known allergy to acetaminophen * female subjects who are pregnant, planning to become pregnant, have recently delivered, or are breast-feeding other protocol-defined inclusion/exclusion criteria may apply

Keywords: erosive osteoarthritis osteoarthritis osteoarthritis of the hand
a pilot analysis of the association between anesthesia induction dosing and aki in the elderly population

Conditions: Acute Kidney Injury; Hypotension; Anesthesia; Adverse Effect

Summary: this study proposes to perform a pilot observational study looking at the doses of propofol used for the induction of general anesthesia and its association with the development of hypotension and aki among elderly patients at ynhh.

the first stage of this study proposes to perform a pilot observational study looking at the doses of propofol used for the induction of general anesthesia. we will determine the percent (as a function of age, elixhauser score, asa status) of patients who receive more than the fda approved induction dosage. we estimate 30% with the power defined as the width of the 95 percent confidence interval around that number that is given by 80% power and n=500. in the second stage, the investigators will look at the association between dose and the development of hypotension (in the time after induction and before surgical incision) and post-operative aki among elderly patients at ynhh while controlling for age, elixhauser score, and asa status. the results of this study will also hopefully be used in a quality improvement project to prevent overdosing of the elderly patient population with induction anesthetic. hypothesis 1: elderly patients are being overdosed (per fda guidelines) with anesthetic agents for induction of general anesthesia. hypothesis 2: overdose of anesthetic agents for induction of general anesthesia in the elderly population leads to an increased chance of developing aki. hypothesis 3: overdose of anesthetic agents for induction of general anesthesia in the elderly population leads to an increased chance of developing hypotension post-induction, which may contribute to development of aki or vice-versa. this research will be done via analysis of data and associated records contained in the multicenter perioperative outcomes group databases at yale (the latter is a research database approved under hic#1206010438). the possible risks are primarily the risk to privacy that is inherent in any retrospective chart review. the benefit may be to suggest areas for quality improvement in induction practices for elderly patients at ynhh and elsewhere.

Eligibility criteria:
inclusion criteria: * patients age 65 or older who underwent induction of general anesthesia at ynhh * only first surgery for each patient within the time period is counted * only include patients who underwent intubation * only include patients who underwent induction by propofol bolus * only include patients who got at least 0.3mg/kg of propofol exclusion criteria: * patients under the age of 65, patients who underwent monitored anesthetic care/conscious mediation for their procedures. * patients with renal failure and/or chronic kidney disease * patients who have a pre-operative systolic blood pressure \<100

Keywords: acute kidney injury hypotension anesthetic dosing induction elderly
freedom inguinal hernia repair system study

Conditions: Primary Inguinal Hernia

Summary: the primary objective of this study is to evaluate patient quality-of-life (qol) after inguinal hernia repair. "carolinas comfort scale" (ccs) assessments will be held at regular intervals. the secondary objective of the study is to follow short-term and long-term study-related complications/adverse events.


Eligibility criteria:
inclusion criteria: * scheduled to undergo routine inguinal hernia repair * competent to give consent * clinically relevant inguinal hernia (classification: nyhus i, ii, iiia) * defect size at operation is between 5mm and 35mm * diagnosed with unilateral, direct, indirect or mixed inguinal hernia * primary hernia at the operative site * male or female * life expectancy of at least 12 months * at least 18 years of age exclusion criteria: * signs of obvious local or systemic infection * any previous surgery on the hernia operative site * hernia is not in the inguinal area * hernia is not identified as indirect or direct * femoral hernias * known collagen disorder * presenting with unstable angina or nyha class of iv * known pregnancy * active drug user * recurrence of a repair by any method * patients with giant inguinoscrotal hernia or abdominal wall defect \>35 mm in diameter - e.g. large direct or combined inguinal hernia type nyhus iiib / ehs p l/m 1/2/3 * immunosuppression, prednisone\>15 mg/day, active chemotherapy * end stage renal disease * abdominal ascites * skin infection in area of surgical field * bmi \>35 * peritoneum cannot be closed
preventive medicine study of childhood atopic diseases

Conditions: Healthy

Summary: under environmental intervention programs, to explore the associations between environmental tobacco smoke (ets) and changes of pulmonary function, cytokines and new-onset asthma between different groups.

environmental intervention programs: we will both interview by telephone and mail the health education leaflets, in order to achieve the following aims: -smokers living with the children will change where smoking takes place for reducing the children's ets exposure. data collection: we will contact participants individually to get informed consent before data collection. no matter what intervention, non-intervention or reference group, all participants will test as follows: * blood sample collection: we will test the total ige, specific ige, cytokines, such as il-4, il-13, tnf-α, ecp and eos. * questionnaire collection * pulmonary function test after intervention programs applied, all participants will test pulmonary function, and total ige, specific ige and cytokines by blood sample after six months by school approaches. then, we can compare the pulmonary function, total ige, specific ige and cytokines before and after intervention programs.

Eligibility criteria:
inclusion criteria: * only one smokers living in the same household * having smoking exposure during the past 12 months while questionnaire surveying * child without smoking habit exclusion criteria: * none of above

Keywords: educational intervention asthma environmental tobacco smoke(ets) children
hyperbaric oxygen therapy for antibiotic refractory pouchitis

Conditions: Pouchitis; Hyperbaric Oxygen Therapy

Summary: the aim of current study is to evaluate the effect of hyperbaric oxygen therapy for the treatment of chronic antibiotic-refractory pouchitis.

pouch ischemia plays an important role in the pathogenesis of pouchitis after ipaa surgery for ulcerative colitis. obese male patients are at high risk for pouchitis because of mesenteric tension. excessive weight gain is associated with an increased risk for pouch failure in patients with restorative proctocolectomy. also, patients with an 's' pouch hardly ever develop chronic pouchitis, owing to the additional length of bowel loop along with mesentery when attached to the anal transitional zone. the treatment of chronic antibiotic-refractory pouchitis(carp) is difficult. hyperbaric oxygen therapy(hbot) have been proven effecitve in the treatment of inflammatory bowel diseases(ibd). meta-analysis revealed that the overall response rate was 86% (85% cd, 88% uc), and of the endoscopic response rate to hbot is 100%. the possible mechanism might be due to the prmoted wound healing by increasing oxygen delivery to hypooxic tissues and changes in inflammatory and immunological mediators. therefore, the aim of current study is to examine the therapeutic effect of hbot for chronic antibiotic-refractory pouchitis(carp).

Eligibility criteria:
inclusion criteria: * ipaa performed for ulcerative colitis; * pouchitis disease activity index (pdai) scores ≥7; * antibiotic refractory pouchitis(carp), defined as patients who do not respond to conventional 2-week, single-agent antibiotic therapy including metronidazole,ornidazole,tinidazole, or ciprofloxacin * 18-75years * informed consent given * able and willing to comply with all trial procedures * including prepouch ileitis exclusion criteria: * crohn's disease of the pouch * pouchitis after ipaa for fap * isolated cuffitis * with cocomttant primary sclerosing cholangitis (psc) * pouch strictures * abscess/sinuses * perianal disease * active malignancy * uncontrolled systemic diseases * history of noninfammatory disease of the pouch * decreased pouch compliance * irritable pouch syndrome * afferent or efferent limb obstruction * needing oral or topical steroid or 5-asa * major physical or psychiatric illness within the last 6m * active use of cholestyramine, nsaids or aspirin * pregnant, breast feeding * clinically significant co-morbidities causing untolerant or unsuitable for hyperbaric oxygen therapy.

Keywords: pouchitis hyperbaric oxygen therapy
a trial to evaluate the safety, local tolerability, pharmacokinetics and pharmacodynamics of lde225 on skin basal cell carcinomas in gorlin syndrome patients

Conditions: Treatment for Basal Cell Carcinomas (BCCs) in Gorlin Syndrome Patients

Summary: part i was a double-blind, randomized, vehicle-controlled proof of concept (poc) study to evaluate the safety, local tolerability, pharmacokinetics and pharmacodynamics of multiple topical administrations of lde225 (a specific smoothened inhibitor) on skin basal cell carcinomas in gorlin's syndrome patients. following a 21-day screening period, patients were exposed to multiple doses of topically applied lde225 twice daily for 4 weeks in a double-blind manner. the patients returned weekly for visits where each bcc was clinically evaluated and digital photographs taken. local safety and tolerability was also assessed. after the last application of treatment, biopsies were taken from treated (both vehicle and lde225) bccs (three per patient) for histology, biomarker evaluation and for pharmacokinetics (skin exposure). in addition, a biopsy from lde225-treated uninvolved perilesional skin was taken for pharmacokinetic evaluation. in total, 4 biopsies were taken: 2 for histology and biomarker and 2 for pk. part ii of this study consisted of a 21-day screening period, a baseline period (directly before commencing the treatment period) and a treatment period of 6 or 9 weeks, depending on randomization. a clinical assessment was performed on site on the last treatment day and if a full clinical response had been observed, approximately 3 weeks after the last treatment an excision of the bcc(s) would have been performed. the study completion visit occurred either 1 week after the excision (when this visit was planned) or 1 week after the last treatment. for a subset of patients, skin biopsies were collected on the last treatment day and an excision of a bcc was also performed at that same visit.


Eligibility criteria:
inclusion criteria: - patients with multiple basal cell carcinomas and gorlin syndrome, or patients with multiple basal cell carcinomas and a mutation in the ptch1 gene at chromosome 9q22.3 exclusion criteria: * previous treatment of the bcc's that are selected for treatment. * any systemic treatment which is known to affect bccs esp. cytostatic treatments, retinoids and photodynamic treatments. other protocol defined incl./excl. criteria may apply.

Keywords: basal cell carcinoma gorlin syndrome, gorlin-goltz syndrome, basal cell nevus syndrome, nevoid basal cell carcinoma syndrome, basal cell carcinoma nevus syndrome
a multi-center trial of nepicastat for cocaine dependence

Conditions: Cocaine Dependence

Summary: the objective of this study is to evaluate the safety and efficacy of nepicastat in improving the number of subjects that achieve abstinence from cocaine and reducing cocaine use in subjects with cocaine dependence.


Eligibility criteria:
inclusion criteria: * be at least 18 years of age * is seeking treatment for cocaine dependence * is able to understand and provide written informed consent * has completed all psychological assessments and procedures required during the 7 - 14 day screening period * if female, agrees to use an acceptable method of birth control * is, in the opinion of the investigator, likely to complete the 11-week treatment phase of the study exclusion criteria: * please contact the study site for more information